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Name
Cemiplimab
Alternate Names
Libtayo
Cemiplimab-rwlc
Abbreviations
None
Category
Biologic therapy (BRM, immunotherapy)
Subcategory
Monoclonal antibody
NSC Number
None
Primary Site
Lung
Skin
Histology
Non small cell lung cancer (NSCLC), SCC, BCC
Remarks
On October 8, 2025, the FDA approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals Inc.) for the adjuvant treatment of adults with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation.
November 8, 2022 New indication: FDA approved cemiplimab-rwlc (Libtayo) in combination with platinum-based chemotherapy for adult patients with advanced non-small cell lung cancer (NSCLC) with no EGFR, ALK, or ROS1 aberrations.
February 22, 2021 FDA approved cemiplimab-rwlc (Libtayo) for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (Tumor Proportion Score [TPS] > 50%) as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations.
February 9, 2021 FDA approved cemiplimab-rwlc for locally advanced and metastatic basal cell carcinoma.
9/28/18: The U.S. Food and Drug Administration today approved Libtayo (cemiplimab-rwlc) injection for intravenous use for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. This is the first FDA approval of a drug specifically for advanced CSCC
November 8, 2022 New indication: FDA approved cemiplimab-rwlc (Libtayo) in combination with platinum-based chemotherapy for adult patients with advanced non-small cell lung cancer (NSCLC) with no EGFR, ALK, or ROS1 aberrations.
February 22, 2021 FDA approved cemiplimab-rwlc (Libtayo) for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (Tumor Proportion Score [TPS] > 50%) as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations.
February 9, 2021 FDA approved cemiplimab-rwlc for locally advanced and metastatic basal cell carcinoma.
9/28/18: The U.S. Food and Drug Administration today approved Libtayo (cemiplimab-rwlc) injection for intravenous use for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. This is the first FDA approval of a drug specifically for advanced CSCC
Coding
This drug should be coded
